Special Report
HPV Vaccination Mandates — Lawmaking amid Political and Scientific Controversy
N Engl J Med 2010; 363:785-791August 19, 2010
- Article
The June 2006 licensure of Merck's human papillomavirus (HPV) vaccine, Gardasil, and the recommendation of the Advisory Committee on Immunization Practices that it be routinely given to girls starting at 11 or 12 years of age set off a flurry of state-level policymaking. The vaccine protects against four strains of HPV, the most common sexually transmitted infection in the country and the major cause of cervical cancer. Within a year, legislators in 41 states had proposed measures intended to increase uptake of the vaccine, including educational campaigns, public subsidies, and insurance-coverage requirements.1
The most contentious proposals were those to make the vaccine mandatory for girls attending school. Bills to make HPV vaccination compulsory were introduced in 24 states, and one state governor imposed a school mandate by executive order (Table 1Table 1
HPV Vaccination-Mandate Bills and Orders in the States, 2006–2008.). Between 2006 and 2008, however, policymakers turned decisively away from the idea that the vaccine should be required for school attendance. As of February 2010, only Virginia and Washington, D.C., had enacted mandates, and Virginia's legislation included an opt-out provision so broad that it may be a misnomer to refer to the law as a mandate.2 Immunization requirements, like all compulsory health measures, are politically and ethically sensitive because they intrude on individual autonomy.3-5 Mandate proposals for HPV vaccination are particularly fraught because they lie at the intersection of two highly charged policy areas: immunization safety and adolescent sexuality. Weighed against these concerns is the success of mandates at achieving high levels of immunization coverage.6
The debate over compulsory HPV immunization represents a case study in public health lawmaking amid political and scientific controversy. Given the centrality of compulsory immunization to the control of vaccine-preventable diseases, it is critical to understand the determinants of policy in this area. We analyzed the policymaking process in a sample of states to identify the factors that were most influential in determining how states acted on the issue of mandates.
Methods
We conducted interviews with 73 key informants in six states that had been actively engaged in legislative and policy deliberations with respect to the HPV vaccine. The states — California, Indiana, New Hampshire, New York, Texas, and Virginia — are diverse geographically and politically and have a wide range of immunization policies (Table 2Table 2
Sources of 73 Key Informants Interviewed for This Study, According to State and Stakeholder Group.). Interview respondents were selected to represent a range of stakeholder groups. Interviews were conducted from August 2008 through May 2009 and generally lasted 45 to 60 minutes. Most interviews were with one key informant, but several involved two to four informants. We analyzed interview transcripts, using methods of thematic content analysis as outlined in a detailed coding manual and using the NVivo 8 software package (QSR International). We also reviewed documentary materials, such as legislative testimony, meeting minutes, position papers, and memoranda. A detailed description of the study methods is provided in the Supplementary Appendix, available with the full text of this article at NEJM.org. The study was approved by the institutional review boards of the Harvard School of Public Health and Columbia University's Mailman School of Public Health.Results
Factors for Proponents
Proponents of compulsory HPV immunization cited the severity of cervical cancer and the efficacy of the vaccine as primary motivations for wanting to ensure that all girls were vaccinated. The vaccine was especially important to some female legislators and champions of women's health issues. Some respondents also noted that a mandate fosters the equitable uptake of a vaccine, ensuring that youth whose parents are less motivated or informed about the benefits will receive it.
These arguments were ultimately overshadowed by several countervailing factors. Respondents reported eight factors that impeded the adoption of school mandates: five relating to characteristics of the HPV vaccine and three relating to the vaccine policymaking process in general. These factors were fairly consistent across states with some variations (Table 3Table 3
Factors Impeding the Adoption of HPV Vaccination Mandates, According to Key Informant Interviews in Six States.).Factors Specific to the HPV Vaccine
Newness of the Vaccine
At the time that mandates were initially proposed, the HPV vaccine had been on the market for only a few months. Many legislators and advocates, along with some public health officials and representatives of medical societies, felt that long-term safety data were needed before mandatory vaccination could be justified. Voicing concern that the vaccine might cause adverse reactions too rare to be detected during premarket clinical trials, respondents asserted that the standard of evidence for mandating a vaccine should be higher than the safety evidence required for approval by the Food and Drug Administration (FDA). In addition to safety concerns, some respondents felt that for a mandate to be acceptable to the public, more time was needed to educate the public about the vaccine and the disease it prevented.
Sexually Transmitted Nature of HPV
A second important factor undermining support for mandates was the sexually transmitted nature of HPV infection. Some social conservatives objected to a compulsory policy because they believed that protecting teenagers against a sexually transmitted disease might undermine prevention messages that emphasize abstinence. Furthermore, respondents indicated that requiring a girl to be vaccinated at the age of 11 or 12 years would force parents to have discussions about sex before they or their children were ready.
These concerns were not limited to organized advocacy groups that identified themselves as conservative. Respondents indicated that a broad range of constituents believed that because parental decision making about children's sexual education and behavior was an especially sensitive area, a compulsory approach was not appropriate for this vaccine.
Nontransmissibility of HPV in the Classroom Setting
The fact that HPV is not contagious through casual contact in the classroom setting emerged as a distinct theme. According to many respondents, the purpose of vaccination mandates is to prevent the spread of contagious disease in schools, not to use school attendance as a lever to achieve other public health goals. These concerns were reportedly a major driver in the decision of the Virginia legislature to include a liberal opt-out provision in its legislation. Respondents reported that making the exemption “broad enough for anybody and everybody to walk through it without a whole bunch of hoops and things that they had to jump through” was crucial to the bill's passage.
Discomfort with the Vaccine Manufacturer's Involvement
A fourth factor that soured many policymakers on mandates was consternation over the involvement of the vaccine's manufacturer, Merck, in the policy process. Merck undertook a multifaceted marketing campaign to promote the passage of mandate legislation. Representatives of the company met with legislators and hired political consultants to promote the vaccine. Merck also provided unrestricted funds to Women in Government, a national organization of female legislators. Many of the bills to require HPV vaccination were introduced by Women in Government members.
Although Merck's lobbying was a key catalyst in the initial push for mandates, many stakeholders came to view the company's efforts as a liability. As media coverage called attention to the company's aggressive tactics, suspicion grew that policy decisions were not being based on the product's merits, and people who were otherwise supportive pulled back. The belief that mandate bills were an effort to make money for the company overshadowed whatever principled arguments might exist for them.
Price of the Vaccine
At $320 for a full course of three doses, Gardasil was considerably more expensive than other required vaccines. Although the federal Vaccines for Children program covers the cost of the vaccine for eligible youth up to the age of 18 years and most private insurers stepped forward quickly to cover it, respondents reported concerns that some families could not afford the vaccine and that it would consume too great a share of states' Medicaid and public health budgets. Some respondents believed that until a financing plan was worked out, a more incremental approach to increasing vaccine uptake was appropriate. Others questioned the cost-effectiveness of the vaccine.
Cost concerns were described as less influential than other factors in the policy debates in most states but loomed large in California, which was having a budget crisis. Although the fiscal implications of a mandate were unclear, the mere possibility that a mandate might impose costs on the state was enough to raise doubts about both the wisdom of mandate legislation and the likelihood that it could escape a gubernatorial veto.
Factors Related to Vaccination Policymaking
Antipathy toward Governmental Coercion
In addition to concerns about the HPV vaccine, decisions about mandates were also strongly influenced by three factors related to the vaccine policymaking process more generally. First, respondents indicated that mandate proposals tapped into generalized antipathy toward governmental coercion among many stakeholders. According to these objections, the bar should be set very high for any governmental intrusion on individual or parental autonomy.
In some states, such as New Hampshire and Texas, resistance to governmental coercion was a strong feature of the state's civic environment in general, regardless of the particular issue involved. In other states, the HPV vaccination issue was dropped into a health-policy environment that was highly fractious because of foregoing debates. Indiana, for example, had recently seen considerable controversy over legislation that mandated mental-health screening for youth. That debate bolstered arguments about excessive governmental coercion to force pharmaceutical products on minors, as well as arguments about drug-company influence. As one respondent said, “Everybody was mad at the pharmaceuticals before Gardasil even got there.”
Antivaccination Activism
The debate was also influenced by general antivaccination activism by organizations and individuals who believed that vaccines cause autism and other health problems in children. Although these groups could not plausibly argue that Gardasil, a vaccine given to adolescents, might cause autism, they reportedly were “using HPV as a tool to get the focus on . . . vaccine safety issues,” according to one respondent. In some cases, they communicated their concerns by making direct contact with lawmakers or testifying at public hearings. In other instances, lawmakers' awareness of previous activism among these groups with respect to other vaccines was sufficient to make them reluctant to enact a mandate, knowing it would face resistance.
Nature of the Policymaking Process
Finally, aspects of the policymaking process itself contributed to the failure of mandate proposals. All five of the sampled states that considered or adopted mandates did so through an act of the legislature or an executive order, rather than through an administrative decision within the department of health, even though health codes in three of the states provided an administrative mechanism. (The sixth state in the survey, New Hampshire, did not consider a mandate.) The legislative process was perceived as insurmountably onerous in some states, with respondents citing such factors as the power of committee chairs, short legislative sessions, and the sheer number of bills competing for attention.
The executive-order mechanism that was used by the Texas governor circumvented these obstacles but provoked the ire of both liberal and conservative legislators and the public. The order took stakeholders by surprise and angered many legislators, who saw it as an overstepping of authority. Subsequent legislative activities centered less on the merits of the vaccine or various policy approaches and more on the significance of allowing the governor to impose a mandate through this process. The legislature's move to explicitly prohibit a mandate for 4 years was largely a symbolic gesture, since a mandate would have had little chance of passing the state's mostly conservative legislature.
In California, too, deliberations over mandating HPV vaccination became entangled with a broader disagreement about who should have authority to enact vaccine mandates. One respondent reported, “The legislators got very adamant about, `We want control over this.' Then there were other stakeholders saying, `Public health [officials] should be able to determine when they want or need a requirement.' So it got into a bigger debate over how requirements should be introduced.”
Discussion
Although school vaccination mandates have been effective at achieving high rates of uptake, they raise numerous political and ethical concerns. This study identifies the most salient factors in policy debates about compulsory HPV vaccination in six states and the ways these factors interacted with one another and with each state's broader sociopolitical environment.
Much of the commentary about HPV vaccination, in both the popular media7,8 and scholarly literature,9,10 has focused on the ways that policy decisions might be swayed by concerns about adolescent sexuality. Our findings present a more complex and dynamic picture. To be sure, social and religious conservatives were prominent in these debates. Fears that the vaccine might foster sexual activity among teens or force parents into unwanted discussions about sex played a role in impeding the enactment of mandates. However, these concerns were part of a much larger spectrum of interrelated beliefs and attitudes. In none of the states we studied were concerns about teen sexuality either a necessary or a sufficient condition for the failure to enact a mandate. Instead, the prospect of compulsory HPV vaccination provoked opposition from an array of groups and individuals with distinct yet complementary concerns.
Our study has limitations. The sample of states was small and not randomized. Although we selected states that represented a diversity of political environments and policy processes and outcomes, the factors that were influential in the sampled states may not be generalizable to other states. The number of respondents who were interviewed in each state was relatively small, and it is possible that some viewpoints were not captured. However, the sample in each state did include representatives of all the major stakeholder groups identified in our recruitment plan.
Our study revealed several points of both consensus and disagreement among the many stakeholders in vaccination policy decisions. There was wide agreement that it was inappropriate to mandate a vaccine within a few months after its licensure. There were fundamental differences of opinion, however, about many other criteria for mandates, including whether they should be applied to vaccines against diseases that are not casually transmissible, how prevalent and severe a disease should be to mandate vaccination, how long a waiting period is appropriate after a vaccine is licensed, and what costs are acceptable. Respondents suggested that policymakers should use the time after the FDA's approval of a new vaccine to carefully build the case for mandates they feel will eventually be desirable, educating and consulting with stakeholders about these issues.
Second, several of the factors leading to the failure of proposals mandating HPV vaccination were rooted in the fact that states already have extensive lists of required vaccines. As the number of recommended childhood vaccines has doubled over the past two decades, policymakers have become increasingly concerned about maintaining public confidence and minimizing the burdens on parents, health officials, and school administrators.11 State health officials expressed concerns that a mandate that was enacted without adequate public support might “end up backfiring and hurting . . . mandates for other vaccines by encouraging parents to opt out more.” The National Vaccine Advisory Committee, too, has recognized the risk of fueling a “culture of refusal.”12 These questions will grow more pressing with each new vaccine that is brought to market, and a default position of automatically adding newly recommended vaccines to the list of school-entry requirements in various states will be untenable. As the Association of Immunization Managers noted in a 2006 position paper, “Mandates must be used sparingly, approached cautiously, and considered only after an appropriate vaccine implementation period.”13
Third, our findings suggest that the legislative process is a suboptimal venue for making immunization policy. Most mandate proposals for HPV vaccination were introduced legislatively, but health codes in two thirds of the states allow health officials to add vaccines to the list of school-entry requirements without legislation.14 Although the enactment of mandates by means of legislation may increase public accountability and transparency, it also opens the process to input from individuals with limited knowledge or understanding of public health principles. In addition, state legislators, particularly part-time legislators, have few resources for in-depth study of health issues. Regardless of their views on the appropriateness of a mandate for HPV vaccination, many health officials in our sample were worried about the problems that could arise from the making of vaccination policy by legislators, such as enactment of a policy that is not evidence based or is difficult to implement logistically or financially. Many respondents described a lack of communication between state legislators and health departments and believed that more cooperation would be beneficial.
Conclusions
Ethical and legal principles dictate that public health laws should use the least restrictive means possible to advance health goals.15 The policymaking dynamics that were illuminated by our study reflect the centrality of this view in politics as well. Robust public health evidence supports the effectiveness of vaccination mandates in achieving high rates of vaccination coverage.6,16,17 However, proposals for coercive measures may trigger backlash — perhaps for reasons largely unrelated to the merits of the particular proposal. This danger underscores the need for careful, individualized assessment of the risks and benefits of each new expansion of the state's reach into citizens' health decisions.
Supported by the Robert Wood Johnson Foundation and the Greenwall Foundation's Faculty Scholars in Bioethics Program.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
We thank Aurora DeMattia and Marie Burks for project assistance, Mary Hunger for transcription, and the National Conference of State Legislators and the Association of State and Territorial Health Officials for guidance on the study design.
Source Information
From the Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York (J.C.); and the Department of Health Policy and Management, Harvard School of Public Health, Boston (S.A., M.M.M.).
Address reprint requests to Dr. Mello at the Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave., Boston, MA 02115, or at mmello@hsph.harvard.edu.
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- Citing Articles (7)
Citing Articles
1
Amrita Mishra, Janice E. Graham. (2012) Risk, choice and the ‘girl vaccine’: Unpacking human papillomavirus (HPV) immunisation. Health, Risk & Society 14:1, 57-69
CrossRef2
Paul L. Reiter, Annie-Laurie McRee, Jessica K. Pepper, Noel T. Brewer. (2012) Default policies and parents’ consent for school-located HPV vaccination. Journal of Behavioral Medicine
CrossRef3
Edna F. Einsiedel. (2011) Publics and Vaccinomics: Beyond Public Understanding of Science. OMICS: A Journal of Integrative Biology 15:9, 607-614
CrossRef4
Robert T. Chen, Dale J. Hu, Eileen Dunne, Michael Shaw, James I. Mullins, Supachai Rerks-Ngarm. (2011) Preparing for the availability of a partially effective HIV vaccine: Some lessons from other licensed vaccines. Vaccine 29:36, 6072-6078
CrossRef5
Scott C. Burris, Evan D. Anderson. (2011) Making the Case for Laws that Improve Health: The Work of the Public Health Law Research National Program Office. The Journal of Law, Medicine & Ethics 39, 15-20
CrossRef6
Janice E Graham, Amrita Mishra. (2011) Global challenges of implementing human papillomavirus vaccines. International Journal for Equity in Health 10:1, 27
CrossRef7
Diane M. Harper, Stephen L. Vierthaler. (2011) Next Generation Cancer Protection: The Bivalent HPV Vaccine for Females. ISRN Obstetrics and Gynecology 2011, 1-20
CrossRef
